Japanese Parasols

Japan (PMDA) Medical Devices Registration

Japan’s medical devices market is estimated to reach $74.7 billion by 2025. In Japan, the medical devices are governed by the Ministry of Health, Labour and Welfare (MHLW), commonly known as Kōrō-shō in Japan. Pharmaceutical and Medical Devices Agency (PMDA), under MHLW regulates the devices developed and commercialized in Japan.

 

Introducing medical devices in Japanese market can be time taking and intensive due to stringent regulations and review timelines. In case the device requires clinical trials, the cost of registration can go significantly high. It is therefore critical for medical devices manufacturers to carefully assess the market potential for their products, competitors, pricing and reimbursement strategy in Japan to fully understand the commercial potential of the product.

Classification of Medical Devices in Japan

Class A: Extremely low risk​ e.g., X-ray film​

Category: Class I general medical devices “Todokede”

Registration pathway: Self declaration. Approval of the product is not required, but marketing notification is necessary.

Class B: Low risk​; e.g., MRI, digestive​ catheters​

Category: Class II controlled medical devices “Ninsho”

Registration pathway:

  • Third party Certification by a registered certification body is required.

  • PMDA approval is required

 

Class C: Medium risk, e.g., dialyzer

Category: Class III & IV Specially controlled medical devices “Shonin”

Registration pathway:

  • Third party Certification by a registered certification body is required.

  • PMDA approval is required

 

Class D: High risk, e.g., pacemaker

Category: Class III & IV Specially controlled medical devices

Registration pathway:

  • PMDA approval is required

Medical Devices Registration in Japan

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Registration Timelines in Japan

Quality System Conformity as per Korean Good Manufacturing Practices is required.

License Holder

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Artixio’s Medical Devices Registration Services in Japan

  • Marketing Authorization Holder (MAH) Services / In Country Care Taker (ICC)

  • Gap Analysis

  • Regulatory Intelligence and Strategy

  • PMA Consultation and Meeting

  • Technical File Preparation and Submission

  • FMA Application Preparation and Submission

  • Quality Management System Implementation

  • Response to PMDA Queries

  • Clinical Evaluation and Post Marketing Evaluation